Events

Recall of SIGNA HDXT 1.5T MR SYSTEM - MAIN UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    24577
  • Event Risk Class
    II
  • Event Initiated Date
    2013-05-14
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    For clariview and screen save from gvtk (gems visualization toolkit) viewer the mr product can generate image headers with nonunique series identifiers which when exported to some pacs systems results in the series being associated with the incorrect study on the pacs. the intended study will not have the correct series listed and an unintended study will have it listed instead. in all cases patient identifying annotation remains correct. the issue may result in an incorrect diagnosis from the study with mixed patient data if the series protocol and anatomy on the studies are similar and the annotation is not noticed. the conditions under which the issue is known to be possible require that the studies have identical time of day (identical hours minutes and seconds) and that the exams be on an affected model of pacs at the same time. this is possible with one scanner on different days or on different scanners on the same day.

Device

SIGNA HDXT 1.5T MR SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: SIGNA HDXT 1.5T MR SYSTEM (Lot serial: 00000287469MR1); Model Catalog: SIGNA HDXT 1.5T MR SYSTEM (Lot serial: 00000284254MR0); Model Catalog: SIGNA HDXT 1.5T MR SYSTEM (Lot serial: 00000304797MR4); Model Catalog: SIGNA HDXT 1.5T MR SYSTEM (Lot serial: 00002UA2400LWN)
  • Product Description
    SIGNA HDXT 1.5T MR SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)